PLEASE NOTE: MEDICINAL PRODUCT NO LONGER AUTHORIZED
What is Clopidogrel Hexal?
Clopidogrel Hexal is a medicine that contains the active substance clopidogrel, available as white round tablets (75 mg).
Clopidogrel Hexal is a 'generic medicine'. This means that it is similar to a 'reference medicine' already authorized in the European Union (EU) called Plavix. For more information on generic medicines, please see the questions and answers by clicking here.
What it is used for
- Clopidogrel Hexal is indicated for the prevention of atherothrombotic events (problems due to blood clots and hardening of the arteries) in adults. Clopidogrel Hexal can be given to the following groups of patients: patients who have had a recent myocardial infarction (heart attack); treatment with Clopidogrel Hexal it can be started between a few days and 35 days after the heart attack;
- patients with recent ischemic stroke (attack caused by insufficient blood supply to one area of the brain); Clopidogrel Hexal can be started between seven days and six months after the stroke;
- patients with peripheral arterial disease (blood circulation problem in the arteries);
- patients with a condition known as "acute coronary syndrome", who are given the medicine with aspirin (another medicine to prevent blood clots), including patients who have a stent (a tube inserted into an "artery to prevent blood clots). prevent obstruction). Clopidogrel Hexal can be used in patients who are having a myocardial attack with "ST segment elevation" (an abnormal reading on the "electrocardiogram or ECG) when your doctor thinks the treatment would be beneficial. It can also be used in patients who do not have one. abnormal reading on the ECG if you have unstable angina (a severe form of chest pain) or myocardial infarction without Q waves.
The medicine can only be obtained with a prescription.
How is Clopidogrel Hexal used?
The standard dose of Clopidogrel Hexal is one 75 mg tablet once a day, with or without meals. In acute coronary syndrome, Clopidogrel Hexal is used together with aspirin and treatment usually begins with a loading dose of four 75 mg tablets. This is then followed by the standard dose of 75 mg once daily for at least four weeks (in ST segment elevation myocardial infarction) or for up to 12 months (in non-ST segment elevation syndrome).
How does Clopidogrel Hexal work?
The active substance in Clopidogrel Hexal, clopidogrel, is an inhibitor of platelet aggregation, which means that it helps prevent the formation of blood clots. Blood clotting occurs by the action of special blood cells, platelets, which aggregate ( stick to each other). Clopidogrel blocks the clumping of platelets by preventing a substance called ADP from binding to a specific receptor on their surface. This prevents platelets from becoming 'sticky', reducing the risk of blood clots forming and helping to prevent blood clots. other heart attack or stroke.
How has Clopidogrel Hexal been studied?
Since Clopidogrel Hexal is a generic medicine, the studies have been limited to evidence designed to show that the medicine is bioequivalent to the reference medicine, Plavix. Two medicines are bioequivalent when they produce the same levels of the active ingredient in the body.
What are the benefits and risks of Clopidogrel Hexal?
Because Clopidogrel Hexal is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.
Why has Clopidogrel Hexal been approved?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with the requirements of EU legislation, Clopidogrel Hexal has been shown to have comparable quality and to be bioequivalent to Plavix. It is the CHMP's view that, as in the case of Plavix, the benefits outweigh the identified risks.The Committee therefore recommended the granting of a marketing authorization for Clopidogrel Hexal.
Other information about Clopidogrel Hexal:
On July 28, 2009, the European Commission granted Acino Pharma GmbH a "Marketing Authorization" for Clopidogrel Hexal, valid throughout the European Union.
For the full version of the Clopidogrel Hexal EPAR click here.
Last update of this summary: 06-2009.
The information on Clopidogrel Hexaò published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
